Fluid container for use with a fluid delivery apparatus

ABSTRACT

A fluid container assembly which can be asceptically filled in the field with selected fluids and one which is specially designed for sterile coupling and use with fluid dispensing and delivery devices of the character that embody stored energy sources such as compressible cellular masses and distendable elastomeric membranes that form, in conjunction with a cooperating base, fluid chambers for containing the fluid to be dispensed.

BACKGROUND OF THE INVENTION

This is a continuation in part application of co-pending applicationSer. No. 08/069,937, filed May 28, 1993, which has now issued as U.S.Pat. No. 5336,188, which is a continuation in part of co-pendingapplication Ser. No. 08/046,438, filed May 18, 1993, which is acontinuation in part of co-pending application Ser. No. 07/987,021,filed Dec. 7, 1992, which has now issued into U.S. Pat. No. 5,279,558,which is a continuation of co-pending application Ser. No. 07/870,269,filed Apr. 17, 1992, which has now issued into U.S. Pat. No. 5,205,820and which is, in turn, a continuation in part of application Ser. No.07/642,208 which has now issued to U.S. Pat. No. 5,169,389 which is acontinuation in part of application Ser. No. 07/367,304 filed Jun. 16,1989 which has now issued to U.S. Pat. No. 5,019,047.

FIELD OF THE INVENTION

The present invention relates generally to fluid delivery devices. Moreparticularly, the invention concerns an improved apparatus for infusingmedicinal agents into an ambulatory patient at specific rates overextended periods of time and to a novel fluid containing vial assemblywhich can be field filled and then used to charge the fluid reservoirsof the fluid delivery apparatus.

DISCUSSION OF THE INVENTION

Many medicinal agents require an intravenous route for administrationthus bypassing the digestive system and precluding degradation by thecatalytic enzymes in the digestive tract and the liver. The use of morepotent medications at elevated concentrations has also increased theneed for accuracy in controlling the delivery of such drugs. Thedelivery device, while not an active pharmacologic agent, may enhancethe activity of the drug by mediating its therapeutic effectiveness.Certain classes of new pharmacologic agents possess a very narrow rangeof therapeutic effectiveness, for instance, too small a dose results inno effect, while too great a dose results in toxic reaction.

In the past, prolonged infusion of fluids has generally beenaccomplished using gravity flow methods, which typically involve the useof intravenous administration sets and the familiar bottle suspendedabove the patient. Such methods are cumbersome, imprecise and requirebed confinement of the patient. Periodic monitoring of the apparatus bythe nurse or doctor is required to detect malfunctions of the infusionapparatus.

Devices from which liquid is expelled from a relatively thick-walledbladder by internal stresses within the distended bladder are well-knownin the prior art. Such bladder, or "balloon" type, devices are describedin U.S. Pat. No. 3,469,578, issued to Bierman and in U.S. Pat. No.4,318,400, issued to Perry. The devices of the aforementioned patentsalso disclose the use of fluid flow restrictors external of the bladderfor regulating the rate of fluid flow from the bladder.

The prior art bladder type infusion devices are not without drawbacks.Generally, because of the very nature of bladder or "balloon"configuration, the devices are unwieldy and are difficult and expensiveto manufacture and use. Further, the devices are somewhat unreliable andtheir fluid discharge rates are frequently imprecise.

The apparatus of the present invention overcomes many of the drawbacksof the prior art by eliminating the bladder and making use of recentlydeveloped elastomeric films, expandable foams and similar materials,which, in cooperation with a base defines a fluid chamber that containsthe fluid which is to be dispensed. The elastomeric film membrane or theexpandable foam member controllably forces fluid within the chamber intofluid flow channels provided in the base.

The elastomeric film materials used in the apparatus of the presentinvention, as well as various alternate constructions of the apparatus,are described in detail in U.S. Pat. No. 5,205,820 issued to the presentinventor. Therefore, U.S. Pat. No. 5,205,820 is hereby incorporated byreference in its entirety as though fully set forth herein. Co-pendingU.S. Ser. No. 08/046,438 filed by the present inventor on Apr. 13, 1993also describes various types of expandable cellular elastomers andelastomeric foams used in making the expandable member of variousphysical embodiments of the invention. This co-pending application isalso hereby incorporated by reference in its entirety as though fullyset forth herein.

The apparatus of the invention can be used with minimal professionalassistance in an alternate health care environment, such as the home. Byway of example, devices of the invention can be comfortably andconveniently removably affixed to the patient's body and can be used forthe continuous infusion of antibiotics, hormones, steroids, bloodclotting agents, analgesics, and like medicinal agents. Similarly, thedevices can be used for I-V chemotherapy and can accurately deliverfluids to the patient in precisely the correct quantities and atextended microfusion rates over time.

One of the devices described in continuation-in-part application Ser.No. 08/069,937 and illustrated in FIGS. 34 and 35 thereof includesfirst, second, and third cooperating fluid chambers which can beselectively filled by individual fluid containers or vials containingvarious fluids such as diluents and medicaments. The novel apparatusshown in FIGS. 34 and 35 permits two or more liquid components to bestored within the reservoirs of the apparatus and then controllablyintermixed at the time of fluid delivery. In an application filedconcurrently with the present application there is described a number ofinventions which expand on inventions described in the Ser. No.08/069,937 application by providing a novel platform support system towhich several fluid dispensers of varying volume can be operablyinterconnected. Both this last mentioned application filed on even dateherewith and application Ser. No. 08/069,937 are incorporated herein byreference as though fully set forth herein.

The present application expands further on the concepts disclosed in theapplications identified in the preceding paragraph by providing a novelfluid container or vial that is usable with the apparatus of theseinventions and is of a unique design which permits it to beexpediciously filled in the field.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an apparatus forexpelling fluids at a precisely controlled rate which is of a compact,low profile, laminate construction. More specifically, it is an objectof the invention to provide such an apparatus which can be used for theprecise infusion of pharmaceutical fluids to an ambulatory patient atcontrolled rates over extended periods of time.

It is a particular object of the invention to provide a device of theaforementioned character which embodies stored energy sources such asdistendable elastomeric membranes, that form in conjunction with acooperating base, fluid chambers for containing the fluids to bedispensed. The novel aseptically field fillable vial assembly of thepresent invention is specially designed for use with these types ofdevices so that they can be expediciously filled in the field shortlybefore use with a wide variety of medicinal fluids.

By way of summary description, the novel vial construction of thepresent invention permits field filling of either individual fluiddispensers of the character described in the preceding paragraphs, oralternatively, permits the field filling of multireservoir devices whichallow for the controlled delivery therefrom of large volumes of the sameor different fluids at controlled rates in accordance with apredetermined delivery protocol.

In one form of the fluid container of the present invention, the fluidchamber thereof can also be quickly and easily filled in the field usinga conventional hypodermic syringe. After filling, the vial assembly canbe coupled with the delivery system in a manner to insure the asceptictransfer of the fluid to be delivered.

Another object of the invention is to provide field fillable vialassemblies of the class described which can be filled and then storedunder refrigeration for an extended period. For those types ofassemblies, a novel temperature indicator is provided as an integralpart of the assembly.

Other objects of the invention are set forth in U.S. Pat. No. 5,205,820and Ser. No. 08/069,937 which are incorporated herein and will becomemore apparent from the discussion which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generally perspective, exploded view of one form of thefield filled vial assembly of the present invention showing it beingfilled by means of a conventional hypodermic syringe.

FIG. 2 is an exploded, generally perspective view of one form of thefluid container or vial assembly of the invention.

FIG. 3 is an enlarged, fragmentary, cross-sectional side view of thevial assembly showing the cap removed and the internal plunger thereofbeing pierced by the syringe needle.

FIG. 4 is a fragmentary, perspective view of one form of the fluiddispenser with which the vial assembly of the present invention can beused.

DESCRIPTION OF THE INVENTION

Referring to the drawings and particularly to FIGS. 1 through 3, oneform of the vial assembly of the invention is there illustrated andgenerally identified by the numeral 12. The apparatus comprises atransparent container, or vial, 14 having a fluid chamber 14a forcontaining the fluid to be added to the reservoir of a fluid dispenseror other fluid delivery device. The fluid can be a diluent or any of themedicaments or beneficial agents described in the previously identifiedU.S. Pat. No. 5,205,820. Vial 14 has open ends 14b and 14c and closelyreceives a pierceable piston-like plunger 16 which is movable withinvial 14 from a first position, shown in FIG. 3, where it is proximateend 14b of the vial to a second position where it is disposed proximateend 14c of the vial. Container 14 can be a glass vial or any othersuitable sterile container for containing the fluid that is to be usedin filling the reservoirs of the fluid dispensers or fluid deliverydevices.

Also forming a part of the vial assembly of the present embodiment ofthe invention is an outer safety casing 18, shown here as comprisingcooperating first and second portions 18a and 18b which are joined toform a sterile barrier system. First portion 18a is provided withthreads 20 and is closed by a threaded closure cap 22. Provided at itsopen end is a socket like construction 24 which is telescopicallyreceived within the open end portion 26 of second casing portion 18b.Outer casing 18 is receivable over vial 14 and portions 18a and 18b areheld in mating engagement by an overwrap 30 which functions as aninterface sterility barrier and upon which appropriate identifyingindicia 31 can be imprinted. A novel temperature indicator means, suchas indicator "T", is also carried by overwrap 30. Indicator "T" may be areversable liquid crystal temperature bar indicator of a character whichis readily commercially available from sources such as Clark Researchand Development of Chicago, Ill., Thermax of Anaheim, Calif. andAmerican Thermo Instruments of Dayton, Ohio. Indicator "T" providesinformation as to the approximate temperature of the vial assemblyduring storage and at time of use. As shown in FIG. 2, a guide bead 32is provided on portion 24. Bead 32a is receivable within a correspondingchannel 33 provided in portion 18b to insure that portions 18a and 18bof the outer casing are properly aligned.

In a manner presently to be described, as the fluid chamber of the vialis filled with fluid using syringe "S" (FIG. 1), penetrable piston 16 ismoved within the vial from the first position shown in FIG. 3 to asecond position wherein it is disposed proximate end 14c. Piston 16 isprovided with a plurality of circumferentially extending sealing beads16a which sealably engage the inner walls 14d of container 14 as thepiston moves rearwardly thereof so as to prevent fluid leakage past thepiston.

Referring now to FIG. 3, after the vial assembly has been assembled inthe manner shown in FIG. 1 and with cap 22 removed, a tear away closurecover 37 is removed. Next the needle "N" of the syringe "S" is used topenetrate a pierceable means shown here as an elastomeric plug 38 whichcloses end 14b of vial 14. As shown in FIG. 3, plug 38 is held inposition within vial 14 by an aluminum crimp cap 40, the periphery ofwhich is crimped over into a circumferential groove 42 providedproximate end 14b of the vial. As fluid is forced from the syringe intoan interior chamber 16b of plunger 16, the plunger will be forced to theleft until it moves into close proximity with end 14c of the vial whereit engages a retainer ring 44 (FIG. 2) that is closely received withinend 14c of the vial. During the vial filling step, air disposed withinchamber 14c will be expelled through a sterile vent patch 45 which isbonded to a closure cap 46 that is provided with vent apertures 46a.

After the vial has been filled with the selected fluid, cap 22 isreconnected with the outer casing 18 so as to maintain the interior ofthe vial in a sealed, aseptic condition. As best seen in FIG. 2, casing18 is provided with an elongated viewing window 50 that permits viewingof the interior chamber 14c of the vial. Similarly, overwrap 30 has anelongated viewing slot 52 which is indexable with slot 50. With thisconstruction, the user can tell at a glance whether the vial is full orempty.

In its sealed, aseptic condition with a sterile fluid path, vialassembly 12 can be stored as may be necessary until it is to be used tofill a fluid dispenser or a reservoir of a delivery apparatus such asthat shown in FIGS. 34 and 35 of U.S. Ser. No. 08/069,937.

Turning now to FIG. 4, the vial assembly is there shown being used tofill the fluid chamber of a fluid dispenser of the character having abase 56, a stored energy means for forming, in conjunction with thebase, a fluid chamber and a cover means which is receivable over thebase for sealably enclosing the stored energy means. The stored energymeans is here shown as comprising a distendable membrane 58, of thegeneral character described in U.S. Pat. No. 5,205,820 at Column 9,Lines 3-59. The cover means here comprises a cover 34 of the generalcharacter shown in FIG. 61 of U.S. Pat. No. 5,205,820.

After tear-away cover 46 has been removed from the vial assembly (FIG.2), the outboard end 60 of the vial assembly, which presents a sterileinterface, is inserted into the likewise sterile inlet opening 62 of thedispenser unit to accomplish a sterile coupling. As indicated in FIG. 4,the dispenser unit is provided with first flow means for establishingsterile fluid communication between the fluid inlet 66 of the reservoirsof the fluid dispenser and chamber 14c of vial 14, when the fillingassemblage is mated with the fluid dispenser. In the embodiment of theinvention, shown in FIG. 4, the first flow means comprises a piercingcannula assembly 68 which includes an outwardly protruding hollowcannula 70. The cannula assembly 68 also includes a housing 72 whichsupports hollow needle 70. Housing 72 is connected to the outboard end84a of an elongated stem 84 which is provided with a central fluidpassageway 86 that communicates with the reservoirs of the fluiddispenser.

After end 60 of the vial assembly is inserted into inlet port 62 of thefluid dispenser, an inward pressure exerted against the vial assemblywill cause hollow cannula 70 to penetrate penetrable piston 16 of thevial assembly opening a fluid flow passageway between passageway 86 ofthe fluid dispenser and chamber 14c of the vial assembly. As shown inFIG. 4, casing 18b of the vial subassembly is provided with amultiplicity of outwardly extending, resiliently deformable lockingelements 88, which comprise a part of the interlocking means of theinvention for interlocking together the vial assembly and the fluiddispenser. Elements 88 are adapted to slide past a multiplicity ofinwardly extending teeth 90 provided within inlet 62 of the fluiddispenser. These teeth are so constructed and arranged as to engageelements 88 in a manner to permit insertion of the vial assembly intothe dispenser inlet but to prevent its removal after it has been fullytelescopically inserted into the inlet of the fluid dispenser. To insureproper alignment between the filling subassembly and the inlet of thefluid dispenser, forward and rearward guide rails 92 and 94 are closelyreceivable within longitudinally extending tracks 96 provided within theinlet of the fluid dispenser. The coupling of the vial assembly with thefluid dispenser is more fully described in the application filedconcurrently herewith.

As previously mentioned, indicator means are provided for indicating thevolume of fluid remaining within vial 14 as the vial assembly isinserted into the inlet of the fluid dispenser. This indicator meanscomprises the previously identified viewing slots 50 and 52 along whichare disposed a multiplicity of indicating indicia 32. Since vial 14 istransparent, the amount of fluid remaining within the vial at any pointin time can readily be determined by merely aligning one of the indiciamarkings on the casing with the inboard extremity of piston 16 as itmoves toward its innermost position.

As previously mentioned, the vial assemblies of the present inventioncan also be conveniently coupled with connector means 414a, 414b and414c of the multireservoir devices illustrated in FIGS. 34 and 35 ofU.S. Ser. No. 08/069,937 and can be used to fill the reservoirs of thesedevices in the manner described in this co-pending application.

Having now described the invention in detail in accordance with therequirements of the patent statutes, those skilled in this art will haveno difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

I claim:
 1. A fluid container assembly for use with a hypodermic syringehaving a piercing cannula, said container assembly comprising:(a) acontainer having a fluid chamber with first and second open ends; (b)pierceable means for sealably closing one of said first and second openends of said container, said pierceable means being pierceable by thepiercing cannula of the syringe; (c) a plunger telescopically movablewithin said container by fluid pressure from a first location proximatesaid pierceable means to a second, spaced-apart location; and (d) anouter casing surrounding said container, said casing having first andsecond ends, one of said first and second ends being closed by a closurecap and the other of said first and second ends being closed by closureassembly comprising a vent patch and a tear away closure cap.
 2. Anapparatus as defined in claim 1 in which said casing is provided withtemperature indicating means for indicating the temperature of theapparatus.
 3. A vial assembly for containing an infusible liquid, saidvial assembly being usable with a syringe having a piercing cannula andcomprising:(a) a container having a liquid chamber with first and secondopen ends; (b) pierceable means for sealably closing one of said firstand second open ends of said container, said pierceable means beingpierceable by a cannula; (c) a plunger telescopically movable withinsaid container by liquid pressure from a first location proximate saidpierceable means to a second, spaced-apart location; and (d) an outercasing surrounding said container, said casing having first and secondends, one of said first and second ends being closed by a closure capand the other of said first and second ends being closed by closureassembly comprising a vent patch and a tear away closure cap.
 4. A vialassembly as defined in claim 3 in which said container is transparentand in which said casing is provided with indicator means for indicatingthe volume of fluid within said chamber of said container and withtemperature indicating means for indicating the temperature of the vialassembly.
 5. A vial assembly as defined in claim 3 in which saidindicator means comprises an elongated viewing window formed in saidcasing and indicating indicia marked on said casing proximate saidwindow.
 6. A vial assembly as defined in claim 5 in which said containercomprises a glass vial and in which said casing comprises first andsecond interconnectable portions.
 7. A vial assembly as defined in claim5 in which said plunger is pierceable by a cannula.
 8. A vial assemblyas defined in claim 5 further including an overwrap surrounding saidcasing.
 9. A fluid container assembly for use with a fluid deliveryapparatus of the character having a base and a stored energy means forforming in conjunction with the base a fluid reservoir having an inletand an outlet, said stored energy means being adapted to expel fluidfrom the fluid chamber, said fluid container assembly comprising:(a) acontainer having a fluid chamber with first and second open ends; (b)pierceable means for sealably closing one of said first and second openends of said container, said pierceable means being pierceable by acannula; (c) a plunger telescopically movable within said container byfluid pressure from a first location proximate said pierceable means toa second, spaced-apart location; and (d) an outer casing surroundingsaid container, said casing having first and second ends, one of saidfirst and second ends being closed by a removable closure cap and theother of said first and second ends being closed by closure assemblycomprising a vent patch and a tear away closure cap.
 10. An apparatus asdefined in claim 9 in which said casing is provided with indicator meansfor indicating the volume of fluid within said chamber of saidcontainer.
 11. An apparatus as defined in claim 10 in which saidindicator means comprises an elongated viewing slot formed in saidcasing and indicating indicia marked on said casing proximate said slot.12. An apparatus as defined in claim 10 further including temperatureindicating means provided on said casing for indicating the temperatureof the apparatus.